Comparing different dosing regimens of Avastin® in the treatment of wet age-related macular degeneration
Wet age-related macular degeneration (wet AMD) happens when abnormal, leaking blood vessels grow inside the eye. It is a leading cause of severe sight loss in people over 50. Eye injections can stop vision from getting worse, but standard treatments can be very costly and regular monthly hospital visits can be tiring for patients. This study, called the TANDEM trial, looked at a medicine called Avastin. Researchers wanted to find out whether a lower dose protects vision just as well as the standard dose. They also wanted to see if having eye checks every two months worked as well as monthly checks. By testing different doses and visit schedules, the researchers hoped to find a safe, effective way to treat wet AMD that requires fewer hospital trips and provides better value for the NHS.
De un vistazo
¿De qué trata este estudio?
Age-related macular degeneration affects the macula, which is the tiny, central part of your eye responsible for sharp, detailed vision. In the 'wet' form of the condition, abnormal blood vessels grow underneath the macula and leak fluid or blood. Without quick treatment, this can lead to rapid and permanent central vision loss, making everyday tasks like reading, recognising faces, or watching television very difficult.
Injections directly into the eye can stop these blood vessels from leaking and save sight. The standard NHS medicine used for this condition works well, but it is very expensive. A similar medicine called Avastin is widely used around the world for wet AMD. Because Avastin is much less expensive, using it could save the NHS significant amounts of money if it is proven to work just as well.
This trial was designed to answer two important questions. First, does a lower dose of Avastin work just as well as the standard dose, while potentially lowering the risk of side effects? Second, do patients really need to visit the hospital every month, or can they safely be checked every two months instead?
Attending hospital clinics every four weeks can be exhausting for older patients and puts a heavy strain on eye clinics. By finding the right balance of medication dose and appointment frequency, the study aimed to make wet AMD care easier for patients while maintaining high standards of safety and sight preservation.
Puntos clave
- The trial compared a lower dose of Avastin against the standard dose for wet AMD.
- It tested whether appointments every two months are as effective as monthly checks.
- Participants received three initial injections followed by top-up injections only when needed.
- The goal was to make treatment easier for patients and more affordable for the NHS.
- Taking part was voluntary, with the freedom to leave the study at any time.
¿Quién puede ser elegible?
This trial was open to men and women aged 50 and over who had recently been diagnosed with wet AMD and had not yet started treatment for it. Participants needed to have a specific level of sight remaining in the affected eye, meaning their vision was reduced by active leakage but not completely lost.
People could not take part if they had already received eye injections or laser therapy for wet AMD in either eye. The trial was also not suitable for people with other eye conditions that damage sight, such as diabetic eye disease, severe short-sightedness, or advanced scarring in the eye.
Additionally, women who were pregnant or breastfeeding, and people who were unable or unwilling to use reliable contraception during the trial, were not able to take part.
¿Podría este estudio ser adecuado para ti?
Responde estas preguntas rápidas para ver si puedes ser elegible. Esto es solo una guía: el equipo de investigación toma la decisión final.
- Are you aged 50 or over?
- Have you recently been diagnosed with wet AMD?
- Have you not yet had any injections or laser treatment in your eye for wet AMD?
- Do you still have measurable vision in the affected eye?
- Are you free from other serious eye diseases, such as diabetic eye disease?
¿En qué consiste la participación?
If you took part in this study, you would first receive three injections of Avastin into your affected eye, spaced four to six weeks apart. Before the trial started, a computer would randomly place you into a group receiving either the standard dose or a lower dose of the medicine.
After your third injection, you would be randomly assigned to a review schedule: either returning for eye checks every month, or every two months. At each review appointment, doctors would test your vision, take detailed scans of the back of your eye, and examine your macula.
You would only receive another injection if your eye checks showed that the abnormal blood vessels were still active or leaking. This approach ensured you only received treatment when your eye truly needed it. The study ran over several years, and you would continue your scheduled visits until your eye stabilised or you chose to leave the study.
Riesgos y beneficios potenciales
Ubicaciones (1)
- Nottingham University Hospitals NHS TrustSolo ciudadNottingham, England
Preguntas comunes
Will the injections into my eye hurt?
Eye injections sound scary, but the clinic team uses local anaesthetic drops to completely numb your eye first. Most people feel a slight sensation of pressure rather than pain.
Is Avastin an experimental drug?
Avastin is already widely used around the world to treat wet AMD. It was originally licensed for bowel cancer, but doctors found that tiny doses injected into the eye work very well for macular conditions.
Can I choose whether I come in every month or every two months?
No. A computer randomly decides whether you are seen every month or every two months so that the researchers can fairly compare both schedules.
What happens if my vision worsens between appointments?
You will be given contact details for the eye clinic so you can be checked urgently between routine visits if you notice any sudden changes in your sight.
Will taking part cost me anything?
No. All study treatments, scans, and appointments are free through the NHS, and you may be able to claim back travel expenses.
Cómo obtener más información
Rebecca Haydock
Siempre hable con su médico de cabecera o especialista antes de decidir participar en un estudio.
Discusión
Discusión comunitaria
Impulsado por nuestro foro en community.patient.info. Por favor, sea respetuoso — esto no es un consejo médico.